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what is the difference between clinical trial study and clinical study?

Medical Sciences Asked by user59763 on November 20, 2020

Can every study that is focused on evaluating the effect of a drug in humans be regarded as a clinical trial study? For example: A study is conducted to find the effect of “Azadirachta indica” on hypertension in humans. Can this be called a clinical trial study?

I think the definition of clinical trial study is a study performed to check the effect of a drug or medicinal agent in humans.

2 Answers

I think the term "clinical study" is broader in meaning than the term 'clinical trial'.

I think a 'clinical trial' is a clinical study to obtain approval for an investigational drug or medical device, and the notion of the 'clinical study' includes studies that are not aimed at obtaining approval.

So, 'the study to find the effect of "Azadirachta indica"' is a clinical study, but I think it is somewhat incongruous to call this a clinical trial. However, if the active ingredient is purified and then sought for approval as a drug, I think it would regarded as a clinical trial.

The website of ClinicalTrials.gov has following descriptions;

There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies.

According to the description above, if it is an interventional study, it might be called a clinical trial.

Answered by Blue Various on November 20, 2020

From https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs:

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.

Note that unlike what the quote says, participants/subjects don't have to be human, e.g. see veterinary clinical trials.

Answered by Franck Dernoncourt on November 20, 2020

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